Manager PQA (Night Shift 12 hour) (6pm-6am)

Role: Quality Assurance Manager overseeing manufacturing and quality systems at Amgen’s Ohio site, with focus on compliance and continuous improvement. Responsibilities: lead and develop QA staff, ensure cGMP, GDP, and regulatory compliance of packaging activities, review and approve deviations, CAPAs, change controls, validation docs, and batch records; drive investigations, manage audit readiness, and foster a culture of quality. Requirements: Master’s or higher degree in Life Sciences, Engineering, or related field with 3+ years QA experience in GMP environment; proven leadership, strong knowledge of quality systems and regulatory expectations; excellent communication and decision-making skills. HighValue: GMP/biotech/pharma, manufacturing/packaging, quality systems (deviations, CAPA, change control), audit management, shift flexibility, leadership experience. WorkSetup: onsite Ohio; shift-based work with potential for evening, night, or weekend hours.